News & Events | FDA - U.S. Food and Drug Administration
WEBFDA news releases, media contacts, speeches, meetings and workshops, and other ways that FDA engages with the public.
FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines …
WEBAug 22, 2024 · Today, the U.S. Food and Drug Administration approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single)...
FDA approves groundbreaking treatment for advanced melanoma - NBC News
WEBThe Food and Drug Administration on Friday approved a new cancer therapy that could one day transform the way a majority of aggressive and advanced tumors are treated. The treatment, called...
FDA Approves Drug with New Mechanism of Action for …
WEB1 day ago · September 26, 2024. Today, the U.S. Food and Drug Administration approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. It is the ...
Fresh from the biotech pipeline: record-breaking FDA approvals
WEBFeb 26, 2024 · The US Food and Drug Administration (FDA) approved a record-breaking 71 new medicines in 2023. There were one or two controversial decisions and a slight drop in first-in-class approvals.
Trial of cell-based therapy for high-risk lymphoma leads to FDA ...
WEBJul 9, 2024 · In September 2022, the FDA designated CD22-targeting CAR-T therapy for large B-cell lymphoma a Breakthrough Therapy, a move that is meant to speed the development and review of particularly promising drugs that may provide a substantial improvement over existing therapies for serious conditions.
Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine at Completion of Blinded ...
WEBSep 22, 2021 · Between December 2020 and February 2021, three vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) received Emergency Use Authorization (EUA) from the Food and Drug...
FDA approves first gene-editing treatment for human illness
WEBDec 8, 2023 · The FDA approved two gene therapies for anyone 12 and older suffering from the most severe form of sickle cell disease, a brutal blood disorder that has long been neglected by medical research.
Approvals News | Today's Latest Stories | Reuters
WEB3 days ago · Healthcare & Pharmaceuticals category · September 26, 2024 US FDA lifts clinical hold on Biomea's diabetes trials after safety review. The U.S. Food and Drug Administration lifted a clinical hold ...
Upcoming FDA Approvals: New Drugs and Therapies That May Be ... - GoodRx
WEBSep 3, 2024 · The bottom line. Over the course of 2024 and into 2025, there are several anticipated approvals, ranging from Zepbound (tirzepatide) for obstructive sleep apnea to suzetrigine for acute pain. New treatments for chronic obstructive pulmonary disease (COPD) and schizophrenia could also be approved.